An Open Labeled Clinical Study to Evaluate the Safety and Efficacy of of Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Chronic Renal Failure Patients. It is Self Funded (Patients' Own Funding) Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Maintain or demonstrate improvement in laboratory values.
研究概览
简要总结
This Study is single arm, single center trial to check the safety and efficacy of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)for the patient with CRF
详细描述
Chronic kidney failure, also called chronic kidney disease, describes the gradual loss of kidney function. Kidney failure is a medical condition in which kidneys fail to filter metabolic wastes and toxins out of the body and a series of symptoms will be developed .It is common, frequently un recognised and often exists together with other conditions (for example, cardiovascular disease and diabetes). When advanced, it also carries a higher risk of mortality. The risk of developing CKD(Chronic Kidney diseases ) increases with increasing age, and some conditions that coexist with CKD become more severe as kidney dysfunction advances CKD can progress to established renal failure in a small but significant percentage of people. This classification divides CKD into five stages. Stages 3-5 may be defined by glomerular filtration rate (GFR) alone, whereas stages 1 and 2 also require the presence of persistent proteinuria, albuminuria or haematuria, or structural abnormalities.
Stem cells have two important characteristics that distinguish them from other types of cells. First, they are unspecialized cells that renew themselves for long periods through cell division. The second is that under certain physiologic or experimental conditions, they can be induced to become cells with special function such as the beating cells of heart muscle or the insulin- producing cells of the pancreas as well as the neurons of brain.So our approach is to prove safety and efficacy of stem cell in CRF
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age limit: 18 -65
- •willingness to undergo Bone marrow and umbilical cord derived Mesenchymal stem cell transplantation.
- •To give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
- •willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
排除标准
- •Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
- •Women who are pregnant or lactating
- •Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
- •Suffering from Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
- •Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
- •Hemoglobin level below 7g %
- •estimated glomerular filtration rate (eGFR) of < 45ml/min
结局指标
主要结局
Maintain or demonstrate improvement in laboratory values.
时间窗: 3 month
• Hematological (Complete blood count (CBC) Complete blood count (CBC) urea(mg/dL), creatinine (mg/dL), plasma calcium(mg/dL), plasma alkaline phosphatase (U/L),plasma phosphorus (mg/dL), plasma cholesterol(mg/dL), plasma HDL-cholesterol (mg/dL), plasma triglyceride (mg/dL), hematocrit (%) and erythrocyte(M/_L) values were evaluated before and at the end of the study.)
次要结局
- pain intensity by VAS(3 month)
- Improvement in SF36(Short form 36) score(3 month)
- the incident of uremia and dialysis requirement(6 month)
- Improvement in subjective global assessment(3 month)
研究者
Dr. Sachin Jamadar
Sub Investigator
Chaitanya Hospital, Pune